FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, Mar 3, 2023
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on March 3, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e1a362ca-fffa-4ada-aad1-912e0a14c1cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201170
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Smiths Medical ASD, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | Not classified | Minneapolis District Office | |
| April 30, 2021 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smiths Medical ASD, Inc.
- FDA Inspection 1239757 - 2024-08-09
- FDA Inspection 1141758 - 2021-04-30
- FDA Inspection 1029368 - 2017-10-12
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